Estonia CTIS Limited-Capacity Participant and Legal Representative Consent Requirements

Start from the main Estonia PIS and ICF

Use the Estonia Patient Information and Consent Requirements guide for the common requirements.

Participant-facing documents must be available in Estonian and include the EU CT number. The legal representative should receive the information needed for the consent decision, while the participant should receive information adapted to their capacity to understand.

When the pathway applies

Conditional. Use the limited-capacity pathway only when the participant cannot give valid informed consent and the trial itself is permitted to include incapacitated participants under Article 31 of Regulation (EU) No 536/2014.

The EU conditions include the need for representative consent, participant information adapted to capacity, respect for refusal or withdrawal, scientific justification for inclusion of this population, and the required benefit, risk and burden conditions.

Do not treat a diagnosis, disability or age alone as proof that a person lacks decision-making capacity.

Legal representative decision in Estonia

Mandatory. The legal representative gives informed consent for the incapacitated participant while taking the participant's presumed intent into account.

Estonian law also states that a representative's decision cannot be relied on where it clearly harms the participant's interests.

The representative document should therefore explain the participant-centred nature of the decision and should not read as a general transfer of control over research choices.

Participant information and dissent

Mandatory. The participant must be informed about the trial and decisions to a reasonable extent. The Clinical Trials Regulation requires information adapted to the participant's capacity to understand.

If the participant is capable of forming an opinion and assessing the information, an explicit wish to refuse participation or withdraw must be respected.

A simplified participant information sheet can be useful where the full representative document would be too complex.

Consent discussion and signatures

Estonian law requires the participant or legal representative, before giving consent, to speak with a trial-team member who is a doctor, nurse or pharmacist, has thorough knowledge of the trial and investigational medicinal product, and can provide a complete explanation.

At the actual consent event, the legal representative and the person conducting the consent interview sign and date the informed-consent record. Add a participant acknowledgement or signature only where it accurately reflects the participant's role and capacity.

Estonia allows legally valid digital signatures. Remote consent is possible only under the national video-call, e-identification and ethics-approval conditions.

Re-consent if capacity changes

If the participant regains capacity during the trial, provide the information needed for the participant to make their own ongoing participation decision and obtain direct consent as appropriate.

The protocol and document set should explain how the site identifies this change and how the new consent is documented.

If capacity fluctuates, avoid a one-time document design that assumes the representative pathway will always remain appropriate.

Reimbursement and compensation

Estonia's ethics guidance states that incapacitated participants and their representatives may not be paid compensation for participation beyond reimbursement of direct costs.

Explain justified reimbursement in the consent materials without creating an incentive that could influence the representative's decision.

Data and sample choices

The representative may need to make decisions about optional data or biological-sample uses when the participant cannot consent. Keep optional future research separate from the core trial.

Where the participant can understand a choice, involve them and respect objection. The Estonia secondary use consent guide explains the optional-use framework.

QC before submission

Check that:

• the protocol permits inclusion of incapacitated participants
• representative authority is handled correctly at site level
• participant information is adapted to capacity
• presumed intent is addressed
• dissent and withdrawal are respected
• direct-cost reimbursement is distinguished from prohibited compensation
• re-consent is planned if capacity changes
• Estonian language versions and EU CT numbers are complete

Use the Estonia patient-facing QC checklist before filing.

Return to the Estonia CTIS hub for the full Estonia guide set.